Trial · NCT01010750

Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

NCT01010750, Phase 1, Completed, Shire; results first posted 2011-02-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD). Trials, record NCT01010750. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01010750

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
NCT number: NCT01010750
Status: Completed
Phases: Phase 1
Enrollment: 18 participants, actual
Lead sponsor: Shire
Conditions: Attention-Deficit Hyperactivity Disorder
Interventions: Lisdexamfetamine Dimesylate (LDX), Immediate Release Mixed Amphetamine Salts (MAS-IR), LDX Placebo + MAS-IR Placebo
First posted: 2009-11-10
Last updated: 2021-06-14
Results first posted: 2011-02-25

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Power of Attention Score	pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7	The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.
Secondary	Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems	2 and 14 hours post-dose on Day 7	Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Secondary	CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness	2 and 14 hours post-dose on Day 7	Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Secondary	CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability	2 and 14 hours post-dose on Day 7	Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Secondary	CAARS-S:S Subscale T-Score: Problems With Self-Concept	2 and 14 hours post-dose on Day 7	Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
Secondary	CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index	2 and 14 hours post-dose on Day 7	Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 \* (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Power of Attention Score	pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7	The Pharmacodynamic Set (PD) is all subjects in the Safety Set who had at least 1 post-dose assessment of the pharmacodynamic variables. The Safety Set contains all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.	milliseconds	MEAN
SECONDARY	Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems	2 and 14 hours post-dose on Day 7	PD	Units on a scale	MEAN
SECONDARY	CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness	2 and 14 hours post-dose on Day 7	PD	Units on a scale	MEAN
SECONDARY	CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability	2 and 14 hours post-dose on Day 7	PD	Units on a scale	MEAN
SECONDARY	CAARS-S:S Subscale T-Score: Problems With Self-Concept	2 and 14 hours post-dose on Day 7	PD	Units on a scale	MEAN
SECONDARY	CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index	2 and 14 hours post-dose on Day 7	PD	Units on a scale	MEAN

Source ClinicalTrials.gov

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Power of Attention Score	LDX 50 mg	half an hour prior to dosing	1260.7	Standard Error 34.000	milliseconds
Power of Attention Score	MAS-IR 20 mg	half an hour prior to dosing	1324.1	Standard Error 47.142	milliseconds
Power of Attention Score	Placebo	half an hour prior to dosing	1272.8	Standard Error 33.729	milliseconds
Power of Attention Score	LDX 50 mg	1 hour post-dose	1244.6	Standard Error 32.887	milliseconds
Power of Attention Score	MAS-IR 20 mg	1 hour post-dose	1307.4	Standard Error 42.908	milliseconds
Power of Attention Score	Placebo	1 hour post-dose	1253.1	Standard Error 24.174	milliseconds
Power of Attention Score	LDX 50 mg	2 hours post-dose	1315.5	Standard Error 67.246	milliseconds
Power of Attention Score	MAS-IR 20 mg	2 hours post-dose	1255.0	Standard Error 33.905	milliseconds
Power of Attention Score	Placebo	2 hours post-dose	1296.2	Standard Error 39.808	milliseconds
Power of Attention Score	LDX 50 mg	3 hours post-dose	1219.1	Standard Error 33.428	milliseconds

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow54

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention	STARTED	LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo	3
First Intervention	STARTED	LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg	4
First Intervention	STARTED	Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg	3
First Intervention	STARTED	Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg	3
First Intervention	STARTED	MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo	2
First Intervention	STARTED	MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg	3
First Intervention	COMPLETED	LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo	3
First Intervention	COMPLETED	LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg	4
First Intervention	COMPLETED	Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg	3
First Intervention	COMPLETED	Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg	3

1 to 10 of 54Source ClinicalTrials.gov

See all 54 participant flow

Adverse events69

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dizziness	Nervous system disorders	LDX 50 mg	1	18	1
other	Dizziness	Nervous system disorders	MAS-IR 20 mg	1	17	1
other	Dizziness	Nervous system disorders	Placebo	1	17	1
other	Headache	Nervous system disorders	LDX 50 mg	1	18	1
other	Headache	Nervous system disorders	MAS-IR 20 mg	1	17	1
other	Headache	Nervous system disorders	Placebo	3	17	3
other	Paraesthesia	Nervous system disorders	LDX 50 mg	1	18	1
other	Paraesthesia	Nervous system disorders	MAS-IR 20 mg	0	17	0
other	Paraesthesia	Nervous system disorders	Placebo	0	17	0
other	Sedation	Nervous system disorders	LDX 50 mg	0	18	0

1 to 10 of 69Source ClinicalTrials.gov

See all 69 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LDX 50 mg
Total, all-cause mortality	MAS-IR 20 mg
Total, all-cause mortality	Placebo
Total, other adverse events	LDX 50 mg	12	18
Total, other adverse events	MAS-IR 20 mg	9	17
Total, other adverse events	Placebo	8	17
Total, serious adverse events	LDX 50 mg	0	18
Total, serious adverse events	MAS-IR 20 mg	0	17
Total, serious adverse events	Placebo	0	17

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24297663	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Choice Reaction Time	Primary outcome	ConductCognition
Simple Reaction Time	Primary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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